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. 2021 Jul 13;24(2):161–166. doi: 10.4103/aja.aja_64_21

Table 3.

Individual adverse events in the East Asian population of the targeted investigational treatment analysis of novel anti-androgen trial (safety population)

Event Apalutamide (total=110), n (%) Placebo (total=110), n (%)


Any grade Grade 3 or 4 Any grade Grade 3 or 4
AE reported in ≥10% of patients
 Hypertension 25 (22.7) 12 (10.9) 16 (14.5) 9 (8.2)
 Weight increased 24 (21.8) 4 (3.6) 40 (36.4) 4 (3.6)
 Weight decreased 20 (18.2) 1 (0.9) 5 (4.5) 0 (0)
 Pruritus 19 (17.3) 0 (0) 9 (8.2) 0 (0)
 Hot flush 18 (16.4) 0 (0) 11 (10.0) 0 (0)
 Upper respiratory tract infection 16 (14.5) 1 (0.9) 11 (10.0) 1 (0.9)
 Viral upper respiratory tract infection 14 (12.7) 0 (0) 13 (11.8) 0 (0)
 Arthralgia 14 (12.7) 0 (0) 12 (10.9) 0 (0)
 Constipation 13 (11.8) 0 (0) 10 (9.1) 0 (0)
 Pain in arm or leg 12 (10.9) 0 (0) 16 (14.5) 1 (0.9)
 Rash, generalized 11 (10.0) 4 (3.6) 1 (0.9) 0 (0)
AE of special interest
 Rash 41 (37.3) 12 (10.9) 10 (9.1) 1 (0.9)
 Fall 3 (2.7) 0 (0) 5 (4.5) 0 (0)
 Fracture 6 (5.5) 1 (0.9) 7 (6.4) 2 (1.8)
 Hypothyroidism 5 (4.5) 0 (0) 0 (0) 0 (0)

AE: adverse event